Endogenous vs. Exogenous Ketone Bodies

Healthy Clinical Trial

Official title:

Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490226
• Other study ID #: ABW-2020-VK
• Status: Completed
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: July 23, 2021

Study information

• Verified date: September 2021
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to compare the origin of ketone bodies: endogenous ketone bodies due to 36 hours fasting or 24 hours of ketogenic diet vs. exogenous ketone bodies as supplements additional to normal diet. Secondary aim of the study is to validate the new metabolic chambers.

Description:

Each study week starts with a 3-day run-in period with controlled diet at home and ends with a test-meal (breakfast) in the lab and following food record over the rest of the day at home. 1. week: physical activity level (PAL) 1.3, 3 intervention days in the metabolic chamber: ad libitum energy intake, washout day, isocaloric diet, 36 hours fasting 2. week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber: isocaloric diet, 36 hours fasting 3. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: ad libitum energy intake, 36 hours fasting 4. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, ketogenic diet (isocaloric) 5. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 23, 2021
• Est. primary completion date: July 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy
• BMI 19-29 kg/m2
• low-medium habitual physical activity
• women using hormonal contraceptive

Exclusion Criteria:

• smoking
• chronic illnesses
• food allergies / intolerances
• vegans and vegetarians
• regular high physical activity (exercise >1 hour/d)
• current weight loss diet / weight loss of >5 kg in the last 3 months
• pregnant / lactating women
• persons incapable of giving informed legal consent

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Beta-Hydroxybutyrate as Ca-Mg-salt, active
24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
• ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active
24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
• fasting, active
36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
• fasting, inactive
36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3. The same intervention is reproduced one week later.

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	appetite control - ghrelin	ghrelin concentration in plasma (24 hour AUC)	24 hours
Primary	appetite control - GLP-1 concentration in plasma	Glucose Like Peptide-1 concentration in plasma (24 hour AUC)	24 hours
Primary	appetite control - PYY concentration in plasma	Peptide YY concentration in plasma (24 hour AUC)	24 hours
Primary	appetite control - subjective feelings of hunger	measured with visual analogue scales (24 hour AUC). The scale consists of a 10 cm vertical line anchored with "not hungry at all" at the left side and with "extremely hungry" at the right side.	24 hours
Primary	appetite control - satiety quotient	satiety quotient of standard test-breakfast after 24 hours of intervention	30 min
Secondary	macronutrient oxidation	measured with indirect calorimetry in a metabolic chamber	24 hours
Secondary	energy expenditure	measured with indirect calorimetry in a metabolic chamber	24 hours
Secondary	glycemia - glucose AUC	glucose AUC from continuous glucose monitoring data	24 hours
Secondary	repeatability of energy expenditure measurements	repeated measurement of 24h-energy expenditure in a metabolic chamber on inactive isocaloric and fasting days	24 hours
Secondary	ß-Hydroxybutyrate concentration in serum	24 hour ß-Hydroxybutyrate concentration in serum (AUC)	24 hours